EP4074338A4 - Préparation pharmaceutique d'anticorps anti-pd-1 stable - Google Patents

Préparation pharmaceutique d'anticorps anti-pd-1 stable

Info

Publication number
EP4074338A4
EP4074338A4 EP20899757.7A EP20899757A EP4074338A4 EP 4074338 A4 EP4074338 A4 EP 4074338A4 EP 20899757 A EP20899757 A EP 20899757A EP 4074338 A4 EP4074338 A4 EP 4074338A4
Authority
EP
European Patent Office
Prior art keywords
pharmaceutical preparation
stable anti
antibody pharmaceutical
antibody
stable
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP20899757.7A
Other languages
German (de)
English (en)
Other versions
EP4074338A1 (fr
Inventor
Young Seok Jung
Ja Hye Hong
Kyung Hee Joo
Young Wook Ha
In Young Oh
In Ae Kim
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Samsung Bioepis Co Ltd
Original Assignee
Samsung Bioepis Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Samsung Bioepis Co Ltd filed Critical Samsung Bioepis Co Ltd
Publication of EP4074338A1 publication Critical patent/EP4074338A1/fr
Publication of EP4074338A4 publication Critical patent/EP4074338A4/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
EP20899757.7A 2019-12-13 2020-12-14 Préparation pharmaceutique d'anticorps anti-pd-1 stable Pending EP4074338A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20190167147 2019-12-13
PCT/KR2020/018247 WO2021118321A1 (fr) 2019-12-13 2020-12-14 Préparation pharmaceutique d'anticorps anti-pd-1 stable

Publications (2)

Publication Number Publication Date
EP4074338A1 EP4074338A1 (fr) 2022-10-19
EP4074338A4 true EP4074338A4 (fr) 2024-03-06

Family

ID=76330229

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20899757.7A Pending EP4074338A4 (fr) 2019-12-13 2020-12-14 Préparation pharmaceutique d'anticorps anti-pd-1 stable

Country Status (7)

Country Link
US (1) US20230054413A1 (fr)
EP (1) EP4074338A4 (fr)
JP (1) JP2023506629A (fr)
KR (1) KR20220115803A (fr)
AU (1) AU2020402369A1 (fr)
TW (1) TW202138006A (fr)
WO (1) WO2021118321A1 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20210097882A (ko) * 2020-01-30 2021-08-10 삼성바이오에피스 주식회사 안정한 항-pd-1 항체 약제학적 제제
BR112023027279A2 (pt) 2021-06-23 2024-03-12 Formycon Ag Composições farmacêuticas líquidas
WO2024006981A1 (fr) * 2022-07-01 2024-01-04 Amgen Inc. Formulations d'anticorps anti-pd -1

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016168716A1 (fr) * 2015-04-17 2016-10-20 Bristol-Myers Squibb Company Compositions comprenant une combinaison d'un anticorps anti-pd-1 et d'un autre anticorps
WO2018204368A1 (fr) * 2017-05-02 2018-11-08 Merck Sharp & Dohme Corp. Formulations stables d'anticorps anti-récepteur de mort programmée 1 (pd-1) et leur utilisation
WO2019129138A1 (fr) * 2017-12-28 2019-07-04 上海细胞治疗研究院 Lymphocytes car-t ciblant la famille des récepteurs erbb et auto-exprimant un anticorps pd-1 et leur utilisation

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RS53072B (en) 2007-06-18 2014-04-30 Merck Sharp & Dohme B.V. HUMAN RECEPTOR ANTIBODIES PROGRAMMED DEATH PD-1
RS61532B1 (sr) * 2015-07-14 2021-04-29 Bristol Myers Squibb Co Postupak lečenja kancera primenom inhibitora imunološke kontrolne tačke; antitelo koje se vezuje za receptor programirane smrti-1 (pd-1) ili ligand programirane smrti-1 (pd-l1)
PT3386541T (pt) * 2015-12-07 2020-10-12 Merck Patent Gmbh Formulação farmacêutica aquosa compreendendo o anticorpo anti-pd-1 avelumab
KR20240011262A (ko) * 2017-02-21 2024-01-25 리제너론 파아마슈티컬스, 인크. 폐암의 치료를 위한 항-pd-1 항체

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016168716A1 (fr) * 2015-04-17 2016-10-20 Bristol-Myers Squibb Company Compositions comprenant une combinaison d'un anticorps anti-pd-1 et d'un autre anticorps
WO2018204368A1 (fr) * 2017-05-02 2018-11-08 Merck Sharp & Dohme Corp. Formulations stables d'anticorps anti-récepteur de mort programmée 1 (pd-1) et leur utilisation
WO2019129138A1 (fr) * 2017-12-28 2019-07-04 上海细胞治疗研究院 Lymphocytes car-t ciblant la famille des récepteurs erbb et auto-exprimant un anticorps pd-1 et leur utilisation

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
GARIDEL PATRICK ET AL: "Stability of buffer-free freeze-dried formulations: A feasibility study of a monoclonal antibody at high protein concentrations", EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS, vol. 97, 1 November 2015 (2015-11-01), NL, pages 125 - 139, XP093121042, ISSN: 0939-6411, DOI: 10.1016/j.ejpb.2015.09.017 *
See also references of WO2021118321A1 *
SVEN BAHRENBURG ET AL: "Buffer-free therapeutic antibody preparations provide a viable alternative to conventionally buffered solutions: From protein buffer capacity prediction to bioprocess applications", BIOTECHNOLOGY JOURNAL, WILEY-VCH VERLAG, WEINHEIM, DE, vol. 10, no. 4, 2 April 2015 (2015-04-02), pages 610 - 622, XP072402691, ISSN: 1860-6768, DOI: 10.1002/BIOT.201400531 *

Also Published As

Publication number Publication date
WO2021118321A1 (fr) 2021-06-17
JP2023506629A (ja) 2023-02-17
EP4074338A1 (fr) 2022-10-19
KR20220115803A (ko) 2022-08-18
US20230054413A1 (en) 2023-02-23
AU2020402369A1 (en) 2022-07-14
TW202138006A (zh) 2021-10-16

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RIC1 Information provided on ipc code assigned before grant

Ipc: A61K 39/00 20060101ALI20240126BHEP

Ipc: C07K 16/28 20060101ALI20240126BHEP

Ipc: A61P 35/00 20060101ALI20240126BHEP

Ipc: A61K 9/00 20060101ALI20240126BHEP

Ipc: A61K 47/22 20060101ALI20240126BHEP

Ipc: A61K 47/18 20170101ALI20240126BHEP

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Ipc: A61K 39/395 20060101AFI20240126BHEP